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SAN ANTONIO -- Half of all benign breast biopsies in premenopausal women with palpable mammographically suspicious breast lesions could safely be avoided through the use of breast bioelectric potential measurements, Dr. David M. Long Jr. said at the annual breast cancer symposium sponsored by the San Antonio Cancer Institute.
Breast bioelectric potential measurement is a novel noninvasive diagnostic tool akin to the ECG and EEG, well-established methods of obtaining key diagnostic information based upon differences in surface electrical activity emanating from the heart and brain he said.
The pressing need for a supplement to mammography stems from its inherent limitations in younger women, who often have greater breast tissue density, which renders the radiographic images difficult to interpret, explained Dr. Long, chairman and medical director of Biofield Corp. in Alpharetta, Ga., the developer of an investigational breast bioelectric potential measurement method known as the Biofield Diagnostic System (BDS).
The company plans to submit an application for marketing approval of the device to the Food and Drug Administration soon.
Dr. Long presented two studies demonstrating what BDS can do. One involved 100 women aged 55 or younger with palpable breast lesions. The false-positive rate for mammography plus clinical examination--as confirmed by a negative biopsy--was 44.3%. With the addition of information provided by the BDS, the revised false-positive rate would have been 22.8%.
Routine use of the BDS in patients with mammographically ...